Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Antibodies, Monoclonal; Basiliximab; Cyclosporine; Cyclosporins; Everolimus; Prednisone; Sirolimus

Criteria

Inclusion Criteria:

• Recipients of a first renal transplant from a primary cadaveric or non-HLA identical living related donor.

• Renal cold ischemic time < 36 hours.

• Age of donor < 65 years.

Exclusion Criteria:

• Patients who have received an investigational drug within 4 weeks of baseline period.

• Patients who are recipients of multiple organ transplants, including any organ other than kidney.

• Recipients of non-heart beating donor organs.

Other protocol-defined exclusion criteria may apply.